Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

A Pre-post Analysis of Healthcare Resource Utilization and Costs of Care in a New User Cohort of Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05613140
• Other study ID #: CLCZ696BUS33
• Status: Completed
• Start date: August 2, 2021
• Est. completion date: November 5, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).

Description:

This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs. Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2). The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9230
• Est. completion date: November 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Cohort 1 - Adult HFrEF patients

• Newly initiated sacubitril/valsartan during the cohort identification period;
• Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
• That are = 18 years old at index date;
• That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
• That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed. Cohort 2 - Adult CHF patients
• Newly initiated sacubitril/valsartan during the cohort identification period;
• Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
• That are = 18 years old at index date;
• That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
• That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.

Exclusion Criteria:

• Patients who died during the post-index period will be excluded.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• sacubitril/valsartan
Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Number of HF-related hospitalizations was defined as the number of acute inpatient hospitalizations with a discharge diagnosis of HF in any position.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Number of all-cause hospitalizations was as the number of acute inpatient hospitalizations for any reason.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan	An UHF visit was defined as any of the following: i) a patient with a place of service (POS) code 20, which corresponds to urgent care facility ii) a patient with an ER visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0450, 0451, 0452, 0456 or 0459 iii) a patient with an urgent care clinic visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0516 or 0526 iv) a patient with a hospital observational stay (POS code = 22, 23), identified from revenue code 0762	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan	Number of WHF episodes was defined as a composite outcome of HF-specific hospitalizations and UHF visits.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Costs of HF-specific hospitalizations was defined as the sum of payer paid amounts for acute inpatient hospitalizations with a primary discharge diagnosis of HF.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Costs of HF-related hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations with a discharge diagnosis of HF in any position.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan	Costs of all-cause hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations for any reason.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan	Costs of UHF visits were defined as the sum of payer paid amounts for UHF visits.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan	Costs of WHF episodes were defined as the sum of payer paid amounts for HF-specific hospitalizations and UHF visits.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan	HF-related costs were defined as the sum of payer paid amounts for medical claims with a diagnosis of HF in any position.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan	All-cause medical costs were defined as the sum of payer paid amounts for all medical claims.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan	All-cause pharmacy costs were defined as the sum of payer paid amounts for all pharmacy claims.	Baseline, 12 months post initiation of sacubitril/valsartan
Secondary	Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan	All-cause total cost of care were defined as the sum of all-cause medical costs and all-cause pharmacy costs.	Baseline, 12 months post initiation of sacubitril/valsartan

External Links

•   Results for CLCZ696BUS33 from the Novartis Clinical Trials Website